MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Information was received from a patient's representative regarding an implantable neurostimulator for the treatment of bladder issues it was reported that the patient's ins dislocated back in october, prompting placement of a new device.The caller asked if the patient's old handset could be used for the newer device.The agent clarified that the device was not compatible and that a replacement must be made through sunmed.The patient's rep was reporting the event and stated, "it dislocated, or disconnected, or whatever you want to call it.So in october, patient went and had a new one put in." patient didn't specifically indicate what "it" was 706433770, excruciating pain.
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Search Alerts/Recalls
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